Human nutrition requires a source of the components of protein, carbohydrates, lipids, vitamins and minerals. Many and varied sources for these nutrient materials have been utilized in the prior art. The prior art does not disclose the concept of providing a balanced supply of nutrients which permits substantially complete absorption of the nutrients which are administered to an individual.
Proteins are associated with all forms of life, an observation that dates back to the original identification of protein as a class by Mulder in 1838. The proteins of living matter act as organic catalysts (enzymes), as structural features of the cell, as messengers (peptide hormones), and as antibodies. The importance of protein in the diet is primarily to act as a source of amino acids, some of which are essential (indispensable) dietary constituents because their carbon skeletons are not synthesized in the bodies of animals. It is known that the adult human requires eight amino acids which are essential for the maintenance of good health. These amino acids are isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan and valine.
Amino acid solutions are commercially available for nutrient I.V. feeding of post operative patients, pediatric patients, patients with renal failure and patients with hepatic failure. The available amino acid I.V. solutions are based on crystalline amino acids which have an advantage over the amino acids solutions which were obtained by hydrolysis of proteins such as fibrin or casein. These solutions were nutritionally incomplete in the amino acid content and caused toxic reactions which led to the banning of these solutions in the United States by the Food and Drug Administration.
Amino acid solutions are available which contain all of the essential amino acids in combination with non-essential amino acids, with or without vitamins, minerals and a carbohydrate and fat source.
To estimate the nutritional value of protein as well as amino acid formulas, the accepted methodology is to determine, during the ingestion of a protein(s) or an amino acid formula, the subject's nitrogen balance. This represents the difference between nitrogen intake and nitrogen output, the difference being either positive (nitrogen retention, as in active growth), negative (nitrogen loss), or zero (nitrogen equilibrium).
In order to carefully determine nitrogen balance (nitrogen intake - nitrogen output), I have used the formula:* EQU B=I-(U+F+S)*
where:
B=Nitrogen Balance PA0 I-Nitrogen Intake PA0 U=Nitrogen Loss In Urine PA0 F=Nitrogen Loss In Feces PA0 S=Nitrogen Dermal Losses PA0 isoleucine; PA0 leucine; PA0 lysine; PA0 methionine; PA0 phenylalanine; PA0 threonine; PA0 tryptophan; and PA0 valine
This formula has been used to compute the Net Nitrogen Utilization (NNU) for the amino acid formulas and proteins that were tested. FNT * Munro, H.N., Crim M.C., in "Modern Nutrition In Health and Disease" Shils, M.E., Young, V.R. (Eds), page 24, Lea & Febiger, Philadelphia 1988
The prior art amino acid solutions, which have widely different ratios of the component amino acids, have not been found to be suitable as total nutrient compositions because after prolonged reliance on these compositions, symptoms of nutrient deficiency are detected due to the low percentage of their net nitrogen utilization (NNU). The low net nitrogen utilization (NNU) results in the presence of unabsorbed amino acids, which are deaminated and cause an increased production of blood urea nitrogen (BUN) as well as increased levels of other metabolic nitrogen containing products. This problem is particularly difficult with patients who have renal failure and/or hepatic disorders.
U.S. Pat. No. 3,697,287 disclose an amino acid food composition which is described as a palatable mixture of the essential and non-essential amino acids, minerals, vitamins, carbohydrates and fats. That composition contains essential and non-essential amino acids. The essential amino acids in such a composition are present in the following ratios:
______________________________________ L-valine 1.0 L-arginine 1.77 L-isoleucine .91 L-lysine 1.03 L-phenylalanine 1.03 L-histidine .44 L-leucine 1.43 L-methionine .93 L-threonine .91 L-tryptophan .28 ______________________________________
I have discovered that the use of an amino acid composition which contains specific proportions of the essential amino acids will make possible a higher NNU as compared to high NNU protein such as hen whole egg protein or other amino acid compositions. I have discovered that the oral administration of a composition which consists of essential amino acids will result in a higher NNU as compared to compositions which also include non-essential amino acids. In addition, the use of a preferred embodiment of the invention, will avoid causing or unduly exacerbating the BUN of patients in which the nitrogen intake is required to be restricted who are fed with certain of the applicant's composition. The avoidance of exogenous residual nitrogen is achieved by the formulation of the amino acid composition with a specific ratio of the essential amino acids which provide for substantially complete absorption of the required quantity of the amino acids. The novel amino acid composition of the invention may be utilized alone or in combination with carbohydrates, lipids, vitamins and minerals depending on the particular nutrient requirements of a particular patient.
I have also discovered that the feeding of the amino acid composition of the invention has a profound immunostimulant effect which can be determined by the means of objective clinical criteria.
The main function of dietary carbohydrate is to provide energy. Administration of carbohydrate has long been known to spare protein in early fasting.
Protein is abruptly lost upon initiating a fast or upon withdrawing carbohydrates from an adequate diet (even if replaced isoenergetically by fat). Glucose is the main carbohydrate in the body and although glucose can be utilized by all cells, it is essential only in a few organs, including the brain and the red cells. Although glucose can be converted to fat, it should be noted that fat cannot be converted to glucose. All the dietary carbohydrates seem to reduce the level of high-density lipoprotein (HDL) cholesterol in the serum, and HDL cholesterol:total cholesterol ratio in the serum is reduced to a greater extent by sucrose than by glucose. The type of dietary carbohydrate can alter the level of triglyceridemia, and this effect can be negated by the addition of polyunsaturated fat to the diet.
Dietary lipids consist mainly of triglycerides (TG), a useful and concentrated source of energy. An adequate TG supply and absorption are especially important for infants and also for adults with a high energy requirement, such as patients with major burns, malignant tumors, and surgical wounds. The alternative energy sources, protein and carbohydrates, deliver per gram, 4 Kcal, less than half the energy density of fats, and require bulky meals to cover high energy requirements. Essential Fatty Acids (EFA) are necessary for the normal function of all tissues, it is therefore not surprising that the list of symptoms of EFA deficiency is a long one. As no animal, including man, can synthesize EFA, it is completely dependent on vegetable lipids to meet EFA requirements.
It has been demonstrated convincingly that diets enriched in EFA such as linoleic acid and reduced in saturated fatty acids do lower significantly LDL and VLDL cholesterol in man at both 30 and 40 in % of fat levels (3).
I have discovered that the oral administration of a composition which contains specific proportion of protein-free carbohydrate and protein-free polyunsaturated vegetable fat results in a palatable mixture having the highest apparent digestibility (AD) a higher Energy Density per weight and per volume and a higher content in EFA joined with a lower content in saturated fatty acids of any natural food or palatable dietetic composition for use as a complement in feeding patients such as infants, alcoholics, drug abusers, Acquired Immune Deficiency Syndrome (AIDS) patients, Aids Related Complex (ARC) patients, cancer patients, psychiatric patients, geriatric patients and the like, who have an increased catabolism, and/or fail to eat, because of a physiological and/or psychological lack of appetite.
Each dietary fuel differs in apparent digestibility (%), which is calculated as: ##EQU1##
To illustrate: If 100 grams of fat are ingested per day, and if the daily stool fat averages 5 grams, then the "apparent digestibility" (AD) of fat is 95%.
I have discovered that the oral administration of a composition which contains specific proportion of mineral-free, protein-free carbohydrate(s) and highly polyunsaturated vegetable fat(s) with the highest content in EFA join with the lowest content in saturated fatty acids, results in a palatable mixture which will avoid causing or unduly exacerbating the level of High-Density Lipoprotein (HDL), Low-density-Lipoprotein (LDL) and Very Low-Density-Lipoprotein (VLDL) cholesterol in the serum of patients in which HDL, LDL and VLDL cholesterol level is required to be restricted who are fed with certain of the applicant's composition.
I have also discovered that the oral administration of a composition which contains specific proportion of mineral free, protein-free carbohydrate and highly polyunsaturated vegetable fat results in a palatable mixture which will avoid causing or unduly exacerbating the Blood Urea Nitrogen (BUN) of patients in which nitrogen intake is required to be restricted who are fed with certain of the applicant's compositions.
I have also discovered a novel concept for providing vitamin and mineral requirements by means of a method which is based on the administration of an amount of vitamins and minerals which is proportionate to the amount of amino acid which are administered.
I also discovered an object of the invention to provide an improved palatable mineral free protein-free carbohydrate and highly polyunsaturated vegetable fat based nutrient composition.
It is also an object of the invention to provide a palatable protein-free carbohydrate and protein-free polyunsaturated fat based composition which is useful because of its highest apparent digestibility (AD) and energy density (ED) in the nutritional support of patients suffering from disease where restricted nitrogen intake is indicated such as in certain renal and hepatic dysfunctions.
It is also an object of the invention to provide a palatable mineral-free protein-free carbohydrate and protein-free highly polyunsaturated vegetable fat based composition a higher apparent digestibility (AD) and energy density (ED) content and a higher EFA content joined with a lower saturated fatty acid content of any natural food or palatable dietetic composition for use as a supplement in feeding patients such as infants, alcoholics, drug abusers, Acquired Immune Deficiency Syndrome (AIDS) patients, Aids Related Complex (ARC) patients, cancer patients, psychiatric patients, geriatric patients and the like, who have an increased catabolism, and/or who fail to eat, because of a physiological and/or psychological lack of appetite.
It is also an object of the invention to provide a mineral-free, protein-free carbohydrate and highly polyunsaturated vegetable fat based composition which has the advantage of low storage and shipping cost which may be used as an emergency food to be shipped by air in response to catastrophic events.
It is also an object of the invention to provide a method for increasing the energy density as well as the apparent digestibility (AD) as well as the EFA content of an unmodified foodstuff by selectively adding a palatable mineral-free, protein-free carbohydrate and highly polyunsaturated vegetable fat based composition, which are absent or are present at a low level, for the purpose of preparing a modified foodstuff which has a higher apparent digestibility (AD) and energy density and EFA content than the unmodified foodstuff.
It is also an object of the invention to provide a mineral-free, protein-free carbohydrate and highly polyunsaturated vegetable fat based composition for use in patients where mineral restriction is required such as cardiovascular patients and renal patients.
It is also an object of the invention to provide a mineral-free, protein-free carbohydrate(s) and highly polyunsaturated vegetable fat(s) based composition for use in patients where the level of HDL, LDL, and VLDL cholesterol level is required to be restricted.
It is also an object of the invention to provide a palatable mineral-free, protein-free carbohydrate(s) and highly polyunsaturated vegetable fat(s) based composition for use as a supplement, source and/or complement to foodstuffs such as milk, dry milk casein, soft drinks, alcoholic drinks, and the like to provide or increase the apparent digestibility (AD), and the energy density, and the EFA content.
It is also an object of the invention to provide a palatable mineral-free, protein-free carbohydrate(s) and highly polyunsaturated vegetable fat(s) based composition for use as a supplement, source and/or complement to foodstuffs such as milk, dry milk casein liquids, soft drinks, alcoholic drinks, and the like to provide or increase the apparent digestibility (AD) and the nutrients content.
It is also an object of the invention to provide a palatable mineral-free, protein-free carbohydrate(s) and highly polyunsaturated vegetable fat(s) based composition which is useful as a complement in the nutritional support of patients who are afflicted with malabsorption.
It is also an object of the invention to provide a palatable mineral-free, protein-free carbohydrate(s) and highly polyunsaturated vegetable fat(s) based composition which is useful in the treatment of Protein-Calorie Malnutrition (PCM).
It is also a primary object of the invention to provide an improved amino acid based nutrient composition.
It is also an object of the invention to provide an amino acid based composition which is useful because of its high NNU in the nutritional support of patients suffering from disease where restricted nitrogen intake is indicated such as in certain renal and hepatic dysfunctions.
It is also an object of the invention to provide an amino acid composition having the highest NNU and protein density (content per volume and per weight) of any natural protein food and/or other amino acid composition for use in feeding patients such as infants, alcoholics, drug abusers, Acquired Immune Deficiency Syndrome (AIDS) patients, Aids Related Complex (ARC) patients, cancer patients, psychiatric patients, geriatric patients, and the like, who have an increased catabolism and/or who fail to eat, because of a physiological and/or psychological lack of appetite.
It is also an object of the invention to provide an amino acid composition which has the advantage of low storage and shipping costs which may be used as an emergency food to be shipped by air in response to catastrophic events.
It is also an object of the invention to provide a method for increasing the amino acid content of an unmodified foodstuff by selectively adding amino acids which are absent or are present at a low level for the purpose of preparing a modified foodstuff which has a higher NNU than the unmodified foodstuff.
It is also an object of the invention to provide a amino acid based composition for use in infant nutrition.
It is also an object of the invention to provide an amino acid based composition which is useful in the treatment and prevention of severe and/or mild obesity as well as over weight.
It is also an object of the invention to provide an amino acid based composition which is useful for the treatment of metabolic anemias.
It is also an object of the invention to provide a mineral free, amino acid based composition for use in patients where mineral restriction is required such as cardiovascular patients and renal patients.
It is also an object of the invention to provide an amino acid based composition for use as a supplement, source and/or complement to foodstuffs such as flours, dry milk solids, casein liquids, soft drinks, alcoholic drinks and the like to provide or increase the net nitrogen utilization (NNU).
It is also an object of the invention to provide an amino acid based composition which is useful in the nutritional support of patients who are afflicted with malabsorption.
It is also an object of the invention to provide an amino acid based composition which has a ratio of essential amino acids that will provide a higher net nitrogen utilization (NNU) as compared to proteins having high NNU such as hen whole egg protein, casein protein, bovine dry milk proteins, soy protein, and the like.
It is also an object of the invention to provide an amino acid based composition which is useful in the treatment of Protein-Calorie Malnutrition (PCM).
These and other objects of the invention will become apparent from the appended specification.